BEUDAMED
    FDA Enforcement Class I Terminated

    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

    Recall: Z-0866-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0866-2015
    Event ID
    69910
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Halyard Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2014
    Initiation Date
    November 17, 2014
    Classification Date
    December 24, 2014
    Termination Date
    August 18, 2015
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076-2190, United States

    Description

    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

    Reason

    The cuff inflation line may detach from the endotracheal tube during use.

    Code Info

    Product Code: 13221, Lot numbers: AA3213, AA3213V01, AA3231, AA3231V01, AA3249, AA3249V02, AA3253, AA3253V01, AA3274, AA3274V03, AA4062, AA4062V02, AA4062V06, AA4097, AA4097V01, AA4097V03, AA4125V01, AA4134V02, AA4140, AA4140V01, AA4142, AA4142V01, AA4146V02, AA4167V03, AA4170 & AA4170V02.

    Distribution

    Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.

    Quantity

    430 cases (10 tubes per case)